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25 items- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Other Events8-K - First Wave BioPharma, Inc. (0001604191) (Filer)
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Material Modification to Rights of Security Holders, Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Regulation FD Disclosure, Financial Statements and Exhibits8-K - First Wave BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma to Change Corporate Name to First Wave BioPharma TodayBOCA RATON, Fla., Sept. 21, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("First Wave" or the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced that it will begin operating under its new corporate name, First Wave BioPharma, Inc., effective today upon the completion of certain filings with the Delaware Secretary of State. The Company's common shares will commence trading on the Nasdaq Capital Market under the new ticker symbol "FWBI" and CUSIP number (33749P101) at the market open on September 22, 2021. Formerly known as AzurRx BioPharma, Inc., the
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - AzurRx BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma CEO Issues Letter to Shareholders Regarding Recent Acquisition of First Wave Bio and Creation of First Wave BioPharmaBOCA RATON, Fla., Sept. 14, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("First Wave BioPharma" or the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today issued a letter to its shareholders from James Sapirstein, President, Chief Executive Officer and Chairman, regarding its recently announced merger with First Wave Bio, Inc. and adoption of the First Wave BioPharma name. The full text of the letter, which has also been posted to the Company's website, is as follows: Dear Shareholders, It is with great excitement and enthusiasm that I write to you, the shar
- INSIDERSEC Form 4 filed by Coelho Mary Theresa4 - AzurRx BioPharma, Inc. (0001604191) (Issuer)
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Termination of a Material Definitive Agreement, Completion of Acquisition or Disposition of Assets, Unregistered Sales of Equity Securities, Regulation FD Disclosure, Other Events, Financial Statements and Exhibits8-K - AzurRx BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma Announces Acquisition of First Wave Bio and its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease IndicationsAzurRx BioPharma to be renamed "First Wave BioPharma" and trade under new NASDAQ ticker symbol, "FWBI" Three IBD clinical indications, including ulcerative colitis and Crohn's disease, added to GI therapeutic pipeline with multiple near-term inflection points Conference call scheduled for today at 8:30 a.m. ET BOCA RATON, Fla., Sept. 13, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has entered a definitive agreement to acquire First Wave Bio, Inc. ("First Wave Bio") in a stock and cash transaction valued
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Material Modification to Rights of Security Holders, Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Regulation FD Disclosure, Financial Statements and Exhibits8-K - AzurRx BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma Announces Reverse Stock SplitBOCA RATON, Fla., Sept. 10, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 10 pre-split shares. AzurRx's common stock will continue to be traded on the NASDAQ Capital Market under the symbol AZRX and will begin trading on a split-adjusted basis when the market opens on Monday, September 13, 2021, under a new CUSIP number, 05502L204. "This is a proactive me
- PRAzurRx BioPharma Activates New Clinical Trial Sites in India for Phase 2 RESERVOIR Trial Evaluating Niclosamide for the Treatment of COVID-19 Gastrointestinal InfectionsBOCA RATON, Fla., Sept. 10, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, therapies for gastrointestinal (GI) diseases, today announced the activation of seven (7) new clinical trial sites in India for the ongoing RESERVOIR trial evaluating FW-1022. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections. The seven new clinical trial sites in India, together with the existing eleven sites in the U.S. and the five trial sites recently added in the Ukraine, brings the total number of RESERVOIR trial
- PRAzurRx BioPharma Announces Positive Results from Independent Data Monitoring Committee Review of Safety Data from Part 1 of RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal InfectionsReview of Interim Safety Data Concluded with Favorable Recommendation to Continue RESERVOIR Trial as Planned Part 2 of RESERVOIR Trial to Enroll Up to 150 Patients to Evaluate Efficacy of FW-1022 and Extend Safety Observations BOCA RATON, Fla., Sept. 09, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that an independent data monitoring committee (DMC) approved initiating patient enrollment in Part 2 of the ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal
- PRAzurRx BioPharma to Present at the Virtual H.C. Wainwright 23rd Annual Global Investment ConferenceBOCA RATON, Fla., Sept. 07, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer of AzurRx, will present virtually at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021. The prerecorded presentation will be available starting at 9:00 a.m. ET on September 13, 2021 and can be accessed via the conference's virtual platform by registered conference attendees. During the presentation, Mr. Sapirstein will provide an overview of AzurRx's bu
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - AzurRx BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma Announces Positive Topline Data For Phase 2 MS1819 Combination Therapy Trial in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency (EPI)MS1819 and PERT combination therapy achieves primary and secondary outcome measure endpointsStudy data indicates clinically meaningful improvement in coefficient of fat absorption (CFA) primary endpoint20-patient study suggests combination therapy may benefit cystic fibrosis patients with severe EPI BOCA RATON, Fla., Aug. 18, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced positive topline results from its Phase 2 Combination Trial evaluating MS1819 in combination with the current standard of care, porcine-derived panc
- INSIDERSEC Form 3 filed by Coelho Mary Theresa3 - AzurRx BioPharma, Inc. (0001604191) (Issuer)
- PRAzurRx BioPharma Announces WHO Publication of "Adrulipase Alfa" as International Nonproprietary Name for MS1819BOCA RATON, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced the World Health Organization (WHO) has published "adrulipase alfa" as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. "The assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in
- SECSEC Form 10-Q filed by AzurRx BioPharma, Inc.10-Q - AzurRx BioPharma, Inc. (0001604191) (Filer)
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Leadership Update, Regulation FD Disclosure, Financial Statements and Exhibits8-K - AzurRx BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma Announces Appointment of Terry Coelho to its Board of DirectorsBOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, therapies for gastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately. The appointment increases the size of AzurRx's Board to seven members. Ms. Coelho currently serves as the Executive Vice President and Chief Financial Officer at BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a commercial-stage specialty pharmaceutical company. During her more than 30-year career, Ms. Coelho has held numerous senior level financial an
- PRAzurRx BioPharma Completes Initial Cohort Enrollment into Part 1 of its RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal InfectionsBOCA RATON, Fla., Aug. 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed enrollment of the initial cohort into Part 1 of its ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide for the treatment of COVID-19-related GI infections. Once all patients in this cohort complete their full two weeks of treatment, the trial's Data Monitoring Committee (D
- PRAzurRx BioPharma Adds New Clinical Trial Sites in Ukraine for Phase 2 RESERVOIR Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal InfectionsBOCA RATON, Fla., Aug. 10, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced the completion of site initiation visits and the addition of five (5) new clinical trial sites in Ukraine for the ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections. The RESERVOIR clinical trial is designed as a two-part
- ANALYSTHC Wainwright & Co. reiterated coverage on AzurRx BioPharma with a new price targetHC Wainwright & Co. reiterated coverage of AzurRx BioPharma with a rating of Buy and set a new price target of $2.00 from $2.50 previously
- SECAzurRx BioPharma, Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Other Events8-K - AzurRx BioPharma, Inc. (0001604191) (Filer)
- PRAzurRx BioPharma Announces Closing of $5.75 Million Bought Deal Offering and Exercise in Full of Underwriter's Option to Purchase Additional SharesBOCA RATON, Fla., July 27, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the closing of its previously announced underwritten public offering of 10,454,546 shares of common stock of the Company, including the exercise in full by the underwriter of the option to purchase an additional 1,363,636 shares of common stock, at a price to the public of $0.55 per share. H.C. Wainwright & Co. acted as the sole book-running manager for the offering. The gross proceeds to the Company, before de